December 12, 2017 - Woodhouse Shanahan has been engaged to provide Food Safety Modernization Act Compliance expertise to iRaiShimp SL, a leading consultancy to the international seafood industry, ... [more]

November 1, 2017. - Charles Woodhouse is Co-author with Barbara Bennett Woodhouse, Professor of Law, Emory University, of a paper titled The Politics of Food. This article is part of the Hofstra ... [more]

Woodhouse Shanahan serves as Counsel for technical Food Law and Food Science issues to Rhythm LLC a leading international design firm thatspecializes in the Consumer Packaged Goods industry. Rhythm ... [more]

September 4, 2017 - Charles Woodhouse has been appointed to the Editorial Board of Sci-Tech Lawyer Magazine. Sci-Tech Lawyer is the flagship quarterly publication of the American Bar Association ... [more]

August 1, 2017. - Our new website is in development at www.food-recall-law.com and will feature our work on food industry Supply-Chain Risk-Management as developed in our recent articles in Sci-Tech ... [more]

June 2, 2017 - In his June 1 announcement of the Administration's decision to withdraw from the Paris Climate Change Agreement, President Trump cited two studies. The popular press - notably the ... [more]

May 1, 2017. - With a press release titled Make School Lunches Great Again, USDA Secretary Purdue has delayed long-standing USDA Sodium Reduction Target I Goals by 3-years to 2020. Thus, American ... [more]

April 28, 2017 - Charles Woodhouse will be Co-presenter with Barbara Bennett Woodhouse, Professor of Law, Emory University, of a paper titled Children's Rights and the Politics of Food. This ... [more]

February 4, 2017 - Charles Woodhouse has published an article which orients Food Industry Attorneys and Food Executives to the important changes in Risk-Management practices which are necessitated ... [more]

January 17, 2017 - FDA has issued a January 2017 Draft Guidance on Listeria Control in RTE Foods. This extraordinarily important and long-awaited document belongs in the Tool Kit of all Food ... [more]

January 6, 2017 - With forthcoming implementation of changes in Nutrition Labeling and revisions to RACCs, practitioners should read the two new Draft Guidances against 81 FR 33742 and 81 FR 34000. ... [more]

January 1, 2017 - We post below the two Presentations and the two Supply-Chain conceptualizations cited in Charles Woodhouse's forthcoming article "Food Lawyers Face Challenges from 21st Century ... [more]

December 14, 2016 - As our readers know, except for infant formula, Open Product Dating is not required by Federal Regulation. Nevertheless, a number of commonly used phrases appear on US food ... [more]

December 12, 2016 - Deputy AG Sally Yates and Assistant Deputy Benjamin Mizer have delivered important remarks in the past week on the prosecution of administrative crimes which include violations ... [more]

November 25, 2016 - An important article from the November 25 issue of Science, titled Republicans Ready a Regulatory Rollback, is must reading for food executives.
Clearly, some provisions of ... [more]

November 10, 2016 - FDA has now issued the Final Guidance Document on the VQIP (Voluntary Qualified Importer Plan). This document addresses one of the final important unresolved issues in FSMA ... [more]

October 12, 2016 - We apologize to our readers for the reduced rate of postings during the Fall Semester. Now that I am back in Graduate School again (for my MS Packaging) and also busy with ... [more]

September 25, 2016 - FDA has now issued an Industry Guidance document clarifying enforcement discretion with respect to the use of the word Healthy on Conventional Food labels. This Guidance ... [more]

August 18, 2016 - FDA has issued a new Revised Draft Guidance for Dietary Supplement NDIs (New Dietary Ingredients) to replace the 2011 Draft Guidance. This document should be studied carefully as ... [more]

August 13, 2016 - The Final Rule on GRAS Notifications and new requirements for substantiation and the qualifications for GRAS Panels have been issued in prepublication form by FDA. Taking up the ... [more]

JULY 15, 2016 - FDA has released an updated Final Rule - Amendment to Registration of Food Facilities. We post the text of 81 FR 45912 July 14, 2016 below. Our readers should update their files ... [more]

July 14, 2016 - S-762 the National Bioengineered Food Disclosure Standard has now passed in both the House and the Senate and the Enrolled Bill has been sent to the President for signature. It is ... [more]

July 6, 2016 - The Eighth Circuit Court of Appeals has upheld the prison sentences for Austin (Jack) DeCoster and his son Peter.
Our readers, as always, are cautioned against reading only "media" ... [more]

June 1, 2016 - On May 27, USFDA released the FSMA Final Rule on Intentional Adulteration. We post below the Federal Register Notice. The Intentional Adulteration (Food Defense) Rule cannot be ... [more]

April 19, 2016 - Charles Woodhouse's article on the Sanitary Transportation FSMA Final Rule appears in the Spring 2016 issue of Food, Cosmetics & Nutraceuticals published by the American Bar ... [more]

April 6, 2016 -- FDA has issued the Final Rule on Sanitary Transportation of Human and Animal Foods. Charles Woodhouse is currently preparing an article on the Sanitary Transportation Rule for the ... [more]

We have recently had several requests for information on statistical sampling protocols and note that it is very difficult to obtain copies of Military Standard 105D issued by the Department of ... [more]

September 10, 2015 - FDA has released the pre-publication texts in advance of the September 17 Federal Register Notices. Our professional regulatory-science readers will now be able to check the ... [more]

July 24, 2015 -- FDA has issued a Supplemental Proposed Rule that would: (1) require declaration of the percent daily value (%DV) for added sugars; and (2) change the current footnote on the ... [more]

July 23, 2015 -- FDA has issued a Draft Guidance on Model Accreditation Standards for Certification Organizations as well as a Proposed Rule on User Fees for accreditation of auditors. We post ... [more]

July 20, 2015 - Swiss Reinsurance has issued two reports on the cost of US Food Recalls which topped $15 Billion in 2013.
Among the key findings are: (1) the number of recalls per year in the US ... [more]

July 16, 2015 - The House Agriculture Committee has approved and sent to the floor "The Safe and Accurate Food Labeling Act of 2015". This bill, if enacted, will accomplish four objectives: (1) ... [more]

July 1, 2015 - As our readers know, the FDA Food Code has been adopted into state law by all 50 states in one of its recent iterations. The Food Code is updated every four years by FDA with the ... [more]

June 17, 2015 - Readers should note today's Federal Register Notice announcing that FDA has removed PHOs from GRAS Status. Partially Hydrogenated Oils must be removed from all foods sold in the USA ... [more]

June 15, 2015 - FDA has now released the Draft Guidance for Industry on the Voluntary Qualified Importer Program (VQIP). For background please read Charles Woodhouse's article from SciTech Lawyer ... [more]

June 10, 2015 - USDA FSIS has released Guidelines for Control of Listeria monocytogenes (Lm) in Retail Delicatessen Operations. Given the numerous recent Food Safety Incidents related to Lm in Deli ... [more]

June 1, 2015 - With important new FSMA Final Rules beginning to issue in the next several months, we again post our article from the Summer 2014 issue of SciTech Lawyer Magazine. This is important ... [more]

May 15, 2015 - The Association of Food Industries has published an article written by Charles Woodhouse (principal author) on Importer Food Safety Vulnerability Review. This article discusses in ... [more]

September, 21, 2014 - Charles Woodhouse, Food Law Attorney and Food Scientist, was an invited speaker at the annual Federal Judges' Training Conference at the Court of Appeals for the Federal Circuit ... [more]

July 10, 2014 - Charles Woodhouse will speak at the Court of International Trade Judges' Tranining Conference in Washington in September. The topic will be the interaction of FSMA (Food Safety ... [more]

June 12, 2014 - The US Supreme Court has issued its decision in Pom Wonderful v. Coca-Cola. The full text of the decision is posted below. This important breaking-news in Food Law will be widely ... [more]

June 11, 2014 - Many of us have been following the media-fuss over the FDA Warning Letter to an artesanal cheesmaker in New York State. The over-reaction of the US artesanal cheese industry has now ... [more]

May 28, 2014 - The Center for Science in the Public Interest (CSPI) has filed a Complaint in Federal District Court (District of Columbia) seeking to compel USDA/FSIS to act on CSPI's May 25, 2011 ... [more]

May 14, 2014 - The FDA has filed a Motion to Dismiss in Center for Food Safety v. Hamburg. Please see our post of February 22 below (a copy of the original Complaint is posted there). Please also ... [more]

April 11, 2014 - A Final Rule on use of Ionizing Radiation for pathogen control in crustaceans is scheduled to issue in the Federal Register on April 14. Absorbed doses of up to 6.0 kiloGray will be ... [more]

April 8, 2014 - We post below the abstract of the article published in the April 2014 issue of the Journal of Animal Science. Readers with access to academic journal services should, of course, ... [more]

April 7, 2014 - The Natural Resources Defense Council has issued a report titled "GRAS: How the Loophole Swallowed the Law".
As our readers know, we generally do not comment on the merits of such ... [more]

April 4, 2014 - The Court of Appeals for the DC Circuit has vacated the March 28 decision (see post below) and has ordered a rehearing en banc on May 19.
Thus, the March 28 decision for USDA is ... [more]

March 28, 2014 - The Court of Appeals for the District of Columbia Circuit has issued a decision in favor of USDA in the Country of Origin (COOL) meat labeling dispute. The 15-page opinion is ... [more]

March 27, 2014 - The European Food Safety Authority has issued, in EFSA Journal, Part II of its series of Scientific Opinions on "risk posed by pathogens in food of non-animal origin" (Salmonella ... [more]

March 10, 2014 - On March 10, the Center for Science in the Public Interest filed a Complaint for Declaratory and Injunctive Relief in the US District Court for the District of Columbia. The ... [more]

February 27, 2014 - USFDA has today released the two pre-publication texts for the Proposed Rules on Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can ... [more]

February 22, 2014 - Under the 1997 Proposed Rule (never issued as a Final Rule), FDA has permitted the Self-Affirmation by Petitioners of GRAS Status for Food Additives for nearly 16 years.
This ... [more]

February 21, 2014 - On February 20, FDA settled the Center for Food Safety lawsuit* with a Consent Decree agreeing to specific dates for the issuance of the "Big Seven" FSMA Final Rules.
We post ... [more]

February 18, 2014 - OSHA has published its Interim Final Rule on Employee Retaliation Protection pursuant to Section 402 of the Food Safety Modernization Act. We have previously commented on this ... [more]

February 7, 2014 - President Obama traveled to Michigan State University today to sign the Agricultural Act of 2014 ("The Farm Bill"). Following the Conference Report on January 27, the House voted ... [more]

February 3, 2014 - FDA has issued its first statement on the criteria to be used in connection with the designation of "high risk foods" pursuant to the requirements of Section 204 of the Food ... [more]

February 1, 2014 - FDA has now issued the last of the "Big Seven" proposed rules pursuant to the Food Safety Modernization Act. The Sanitary Transportation Rule is estimated by FDA to affect some ... [more]

January 28, 2014 - As the Agriculture Act of 2014 ("The Farm Bill") moves to a final vote in the House, the Food Safety Insurance Study remains in the Bill. This provision instructs the FCIC ... [more]

January 28, 2014 - Despite extensive discussions between FDA and produce growers, dealers, and retailers, Section 12311 of the Agricultural Act of 2014 ("Farm Bill") does not appear to require any ... [more]

FDA has updated GFI 209, 213 with New Guidance on Antimicrobial Use in Food Animal Production.
As has been FDA's practice thusfar, reliance is placed upon voluntary guidelines.
A PDF of the Draft ... [more]

We thank our readers for their patience during our first semester of teaching US Food Import Regulation. We will now reaume our normal pace of postings on important developments in food regulation ... [more]

I apologize for the temporary suspension. This semester I am teaching a new graduate (LLM) course at MSU College of Law - US Food Imports: Process, Regulation, and Food Safety. This topic is very ... [more]

July 1, 2013 We post an updated essay "Preparing for the Food Safety Modernization Act" as we wait for the release, by USFDA, of the Proposed Rules on the Voluntary Qualified Importer Program ... [more]

May 30, 2013 - This week FDA, pursuant to the requirements of the FSMA, issued a advanced copy of the Final Prior Notice Rule. When the official Federal Register Notice issues (in a few days) we will ... [more]

May 14, 2013 In a unanimous decision written by Associate Justice Elena Kagan, the US Supreme Court has affirmed that the doctrine of patent-exhaustion does not apply recombinant DNA technology. ... [more]

May 3, 2013 The interagency FDA and USDA working group has issued a Risk Assessment for Listeria at the retail deli level. All Food Safety professionals working on RTE Foods need to review this ... [more]

The March 3 issue of Emerging Infectious Diseases contains a major study tabulating 1998-2008 United States data for hospitalizations and deaths attributed to some 17 food commodities. During this ... [more]

We post below the link to the major research study on the Mediterranean Diet and Cardiovascular Disease published in the New England Journal of Medicine on Feb. 25, 2013.
You may access the full ... [more]

Groeb Farms of Onsted, MI and Honey Holdings of Baytown, TX have signed Deferred Prosecution Agreements (DPAs) with the Justice Department in one of the largest cases of Antidumping Duty evasion in ... [more]

On February 21, the US Department of Justice announced the criminal prosecution of individual corporate officers and employees related to the 2009 peanut products related Salmonella outbreak. This ... [more]

Although advanced copies have been widely circulated to seafood industry insiders, Oceana has now permitted release of its new (Feb. 21, 2013) survey on seafood species substitution at the retail and ... [more]

Representatives Peter DeFazio (D-OR) and Jared Polis (D-CO) have announced that they will introduce national legislation to require GMO labeling on human food products. The text of the bill is not ... [more]

As required by Congress, FDA has issued its Summary Report - Antimicrobials Sold or Distributed for Use in Food-Producing Animals – 2011. This release was accompanied by the release by CDC of ... [more]

As expected, on February 5, FDA issued as a Final Rule "Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption". The Final Rule issued without change from the text ... [more]

The January 25, 2013 issue of MMWR (Vol. 62, No. 3) includes the report on Foodborne Disease Outbreak Surveillance Data for 2009-2010.
For the convenience of our readers we have posted pages 41-47 ... [more]

In the January 25 issue of MMWR (Mortality and Morbidity Weekly Report) the CDC has published the "Surveillance for Foodborne Disease Outbreaks 2009-2010" data analysis.
We post the report below: [more]

On January 4, FDA released the Proposed Rules under the FSMA for both Produce Safety and for Risk-Based Preventative Controls. We will be preparing reviews of both documents for submission to the ... [more]

Industry observers are becoming increasingly critical of FDA's protracted delay in issuance of important FSMA (Food Safety Modernization Act) Proposed Rules, some of which have been held at OMB ... [more]

The extraordinary controversy caused by the revelation of CFIA (Canadian Food Inspection Agency) memos dating back as far as 2008 is raising serious questions about Food Safety both in Canada and ... [more]

The Safe Food for Canadians Act had its Senate Third Reading on October 17 and its House of Commons Second Reading October 23.
Following the approval of the Standing Committee on Agriculture and ... [more]

While we generally confine our comments on FDA matters to Food and Dietary Supplements, the lessons of the ongoing regulatory failure in the compounding pharmacy scandal should prove valuable to ... [more]

Because of the extraordinary potential impact of Proposition 37 on US Food labeling, we follow this controversy closely. Both the EU's EFSA (Oct 4) and Germany's BfR (Oct 1) have published reviews ... [more]

In view of Proposition 37 being on the ballot in California six weeks from now (see our June 15, 2012 post), we call our readers’ attention to a Food and Chemical Toxicology journal article in ... [more]

Congressmen Steve King (R-IA) and Tim Huelskamp (R-KS) have introduced the "No Hungry Kids Act" which seeks to overturn School Lunch Program Nutrition Standards issued by the USDA in January ... [more]

The search for statistically significant evidence as to the possible association of health benefits with consumption of organic foods continues. Please see our posts on the UK’s FSA study (July ... [more]

Two non-profit advocacy groups - the Center for Food Safety and the Center for Environmental Health – have filed a complaint for declaratory and injunctive relief against FDA. The complaint, ... [more]

The Safe Food Coalition has again written to USDA Secretary Tom Vilsack urging action on required labeling for mechanically tenderized non-intact beef products. Here are two statements from the USDA ... [more]

Thirteen US Senators have addressed a letter to FDA Commissioner Margaret Hamburg asking for stronger restrictions on antimicrobial use in food-animal production. The request focuses upon the two, ... [more]

The FDA has released its second Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices. Although the Report contains relatively little new information, some instructive statistics ... [more]

The Canadian Food Inspection Agency (CFIA) has released its draft proposal for the Canadian Unified Food Safety System for a comment period which will remain open until October 31. Regulatory Food ... [more]

An in-depth study of FDA Food Advisory and Food Recall Procedures has been issued by the Government Accountability Office (GAO). This is timely information since Congress is considering adding a ... [more]

Congressman Dennis Cardoza (D-CA) has introduced in the House, a parallel to the Senate Feinstein-Chambliss amendment to the 2012 Farm Bill. Cardoza's amendment would require USDA-RMA to study the ... [more]

There are a number of provisions in the current Senate and House versions of the 2012 Farm Bill that are of major importance to the Produce Industry.
To facilitate our ongoing discussion, we post the ... [more]

California Secretary of State Debra Bowen has certified "The California Right to Know Genetically Engineered Food Act" for the November 2012 General Election ballot. The popular press has, as usual, ... [more]

On June 7, the Harper Government introduced legislation to reform and unify the Canadian Food Safety system. We post below a complete text of The Safe Food for Canadians Act (S-11, 1st Session, 41st ... [more]

With reference to our posts of April 17, 2012, March 23, 2012 and May 27, 2011, United States Magistrate Judge Theodore H. Katz has once again issued an Order in favor of the National Resources ... [more]

Food Labeling and Food Science professionals have been awaiting the decision of FDA on the Petition of the Corn Refiners Association to permit HFCS to be labeled as "Corn Sugar". The FDA decision, ... [more]

Regulatory Food Science professionals should read the opinion piece published in this week’s issue of Nature by Harvard University Government Professor Daniel Carpenter. Science professionals ... [more]

California State Senator Ted Lieu, one of the country's most active state legislators in the area of Food Safety, has asked USDA/FSIS to regulate the use of transglutaminase (referred to in the ... [more]

As our readers know, we follow nanotechnology developments in the areas of food additives and food contact materials with great interest. Both in the European Union and in the US, regulators are ... [more]

Lieutenant Colonel William C. Shanahan, founding principal of Woodhouse Shanahan, has returned from his tour of duty with the US Army in support of Operation Enduring Freedom in the Afghanistan ... [more]

Charles Woodhouse will be a featured speaker on Produce Food Safety Compliance and Food Recall Management at the July 2012 Food Regulation Current Issues Seminar at Michigan State University in East ... [more]

This document, released on April 13, is a valuable resource for industry professionals primarily because of its excellent and detailed summary of reports, reviews, and peer-reviewed articles on this ... [more]

On March 30, USFDA rejected a petition by the Natural Resources Defense Council (NRDC) and other environmental groups to ban bisphenol-A (BPA), saying there was not enough scientific evidence to ... [more]

With reference to our post of May 27, 2011, United States Magistrate Judge Theodore H. Katz has issued an Order in favor of the National Resources Defense Council (NRDC)
The National Resources ... [more]

An article which is likely to receive considerable attention will appear in the April issue of Scientific American. The article, entitled Food Poisoning’s Hidden Legacy is written by science ... [more]

The Center for Science in the Public Interest has issued a White Paper titled "Antibiotic Resistance in Foodborne Pathogens: Evidence of the Need for a Risk Management Strategy". The documents is an ... [more]

At the current International Conference on Emerging Infectious Diseases in Atlanta, CDC researcher Hannah Gould has presented data which may indicate an increase in the prevalence of foodborne ... [more]

Led by Senator Barbara Boxer (D-CA) and Congressman Peter DeFazio (D-OR), fifty-five Members of Congress have written to FDA Commissioner Margaret Hamburg urging her to require labeling of GE ... [more]

On February 15, the European Commission and USDA signed an Equivalency Agreement granting mutual recognition of US and EU organic standards for most food products.
We post the Letter from USDA and ... [more]

The Fiscal year 2013 Budget of the U. S. Government was released by the Office of Management and Budget on February 13. As we are dissatisfied by simplistic journalistic reviews of the Budget in the ... [more]

Posted below is the February 7 FSIS Constituent Update Special Edition. FSIS has extended from March 5, 2012 to June 4 2012, the implementation of routine sampling of ground-beef and its precursor ... [more]

U.S. Representative Scott DesJarlais (R-TN) has introduced H.R. 3848 the "Protecting Foods and Beverages from Government Attack Act of 2012". This legislation would prohibit the use of federal money ... [more]

The first revisions since 1983 for statistical sampling and inspection of food containers - Standards for Condition of Food Containers – have been issued for comment by the USDA Agricultural ... [more]

The House Energy and Commerce Committee has issued a Report on the 2011 Listeria monocytogenes Outbreak associated with Cantaloupe. The Report is highly critical of the role of third-party auditors ... [more]

On January 4, FDA issued a Press Release and Q&A on the Order of Prohibition that will issue in the next several days. The extra-label use of cephalosporin drugs in major food-producing animals ... [more]

A group of environmental and consumer organizations, led by the International Center for Technology Assessment, has filed a complaint in the US District Court for the Northern District of California ... [more]

In the December 23 issue of MMWR (Morbidity and Mortality Weekly Report), the CDC has published a report which evaluates the challenges facing state Food Safety Epidemiology systems in an era of ... [more]

The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is proposing a new rule that will allow establishments to label a broader range of products without first ... [more]

On November 23, 2011, the European Commission Health and Consumers Directorate-General (DG-SANCO) issued EU Guidance to the Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and ... [more]

The long-awaited EU recommended definition of Nanomaterials was published on October 20 in the Official Journal (OJ L 275/38-40).
The definition reads (in part): Nanomaterial means a natural, ... [more]

In September, USDA / FSIS announced that it intends to carry out verification procedures, including sampling and testing of manufacturing trim and other raw ground beef components, to ensure control ... [more]

The long awaited Food Information Regulation was published in the Official Journal (L) of the European Union on November 22. The citation is Reg. (EU) 1169/2011. OJ(L) 304/18, 22 Nov 2011.
The full ... [more]

In the weeks ahead, students and practitioners of food labeling will be studying the WTO Panel’s decision on the consolidated cases WT/DS 384 (Canada) and WT/DS 386 (Mexico).
In 2008, Canada ... [more]

FSIS is delaying the effective date of the final rule that will require nutrition labeling of the major cuts of single-ingredient, raw meat and poultry products and ground or chopped meat and poultry ... [more]

A study at Johns Hopkins University details findings regarding veterinary drug residues in seafood products. Copyright restrictions prevent us from posting the study. However, we post the abstract ... [more]

Charles Woodhouse has published a White Paper on the imported food provisions of the Food Safety Modernization Act. This paper is a version of materials prepared by Mr. Woodhouse as Guest Instructor ... [more]

The CDC has announced that, as of November 1, 2011, a total of 139 persons have been infected with one of the four outbreak-associated strains of Listeria monocytogenes. Twenty-nine deaths and ... [more]

The Institute of Medicine (IOM) of the National Academies has issued a report entitled "Front-of-Package Nutrition Rating Systems and Symbols: Promoting Healthier Choices". The report supports a ... [more]

We have previously posted (October 8) the Court of Justice of the European Union (ECJ) decision in Bablok v. Freistaat Bayern noting that it has created considerable confusion and controversy among ... [more]

The Government Accountability Office (GAO), the investigative arm of Congress, has issued a report which highlights the need for FDA and the ISSC (Interstate Shellfish Sanitation Conference) to ... [more]

The Center for Science in the Public Interest (CSPI) has filed a class action suit against General Mills for allegedly deceptive advertising of "Fruit Roll-ups".
The action was filed today in the US ... [more]

The Court of Justice of the European Union (ECJ) decision in Bablok v. Freistaat Bayern has created considerable confusion and controversy among students and practitioners who follow European GMO ... [more]

The Center for Food Safety, a Washington based advocacy group, has filed a Petition with USFDA to require the labeling of all foods produced with Genetic Engineering technology. We express no opinion ... [more]

The Food Information Regulation (FIR) will be the most significant change in European Food Labeling in 30 years. The vote by the European Council now clears the way for publication in the Official ... [more]

FDA has released the first 2009 Food Code Supplement and has also announced its Retail Food Safety Action Plan.
The Food Code Supplement is posted below as is the Press Release for the Retail Food ... [more]

Thirty-six prominent American law professors have written to the heads of the FTC, the FDA, the USDA, and the CDC to express their collective judgment that the Preliminary Proposed Nutrition ... [more]

A GAO Report issued this week is sharply critical of the apparent lack of diligence of USFDA and USDA in addressing the problems of antimicrobial use in food animal production and the development of ... [more]

Senator Kirsten Gillibrand has introduced the Foodborne Illness Reduction Act to reform USDA and FSIS Food Safety Programs. This Bill addresses issues not reached in the FSMA. As a service to our ... [more]

Researchers at the National Institute of Health Sciences in Japan have published a paper in the current issue of Epidemiology and Infection which provides guidance for the relative risk-assessment of ... [more]

Ireland Issues Guidelines for Ready-to-Eat (RTE) Sprouted Seeds
The Food Safety Authority of Ireland (FSAI) has published guidelines for the safe production of sprouted seeds to be consumed raw, ... [more]

We express no opinion with respect to the merits of the present matter before the US District Court for the District of Maryland in the matter of Del Monte Fresh v. USFDA. However, we post below the ... [more]

USFDA has issued a new "White Paper" titled "Advancing Regulatory Science at FDA". As used by FDA Commissioner Margaret Hamburg, the term "Regulatory Science" means the use of evidence-based science ... [more]

USFDA has announced in the Federal Register its first User Fee Schedules in connection with implementation of the Food Safety Modernization Act. The schedules cover fees for domestic and foreign ... [more]

The U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) has issued a proposed rule on labeling of meat and poultry containing injections, marinades, and other added ... [more]

EFSA has released a Scientific Opinion updating its assessment of the state of present knowledge of the etiology and control of viral foodborne illness.
The text of the 91 page document is posted ... [more]

As discussed in our earlier post, the text of the July 6 Resolution of the European Parliament provides significant insight into the final amendments to the Food Information Regulation (FIR) that ... [more]

On July 5, the European Parliament will vote on a wide range of proposed changes in food labeling. The full text has remained unpublished, but a preview of the changes was released on July 29 and is ... [more]

EFSA (the European Food Safety Authority) has released an updated Risk Assessment in consideration of the HUS (Haemolytic Uremic Syndrome) cases in France. Additionally Eurosurveillance, published by ... [more]

The Inspector General (IG) of HHS (Health and Human Services) has issued an investigative report which points to serious flaws in USFDA's administration of recalls of imported foods. The IG surveyed ... [more]

The U.S. Food and Drug Administration (USFDA) has issued a new Policy Report entitled, "Pathway to Global Product Safety and Quality". The Policy Report discusses the challenges facing USFDA in the ... [more]

A research team, headed by Dr. Ruchi Gupta of Northwestern University, has published its findings in the July issue of Pediatrics.
The report titled, “The Prevalence, Severity, and Distribution ... [more]

The Food and Drug Administration (FDA) has issued a Draft Guidance for Industry document which gives nanotechnology stakeholders their first insight into FDA’s thinking about the probable scope ... [more]

The European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA) have issued a Technical Report on the recent STEC/VTEC outbreak in Germany.
Citation: Shiga ... [more]

Conservation International and the WorldFish Center have issued a major report based upon Life Cycle Analysis (LCA) of Aquaculture as compared with other Center-of-the Plate animal protein production ... [more]

In the June 10 issue of MMWR (Morbidity and Mortality Weekly Report), the CDC (Centers for Disease Control) has released the 2010 data from the Foodborne Illness Active Surveillance System.
This is ... [more]

As background to this announcement, NOAA (National Oceanic and Atmospheric Administration) calls attention to the poor performance of US policy makers with respect to job-creation in this industry ... [more]

The National Resources Defense Council (NRDC) and a coalition of other environmental groups including the Center for Science in the Public Interest (CPSI), and the Union of Concerned Scientists have ... [more]

In response to recent communications from readers, we are providing an update on the status of NOP (National Organic Program) progress towards the implementation of the Organic Apiculture Standard. ... [more]

The GAO (Government Accountability Office), the investigative arm of the US Congress, has issued another report in its series of analyses of the performance of USFDA and USDA in the protection of US ... [more]

The first issuance of rules under the Food Safety Modernization Act (FSMA) were released by USFDA on May 5.
The Press Release is attached as well as the two Federal Register Notices.
Effective July ... [more]

On April 28, the Interagency Working Group on Food Marketed to Children - consisting of the Federal Trade Commission (FTC), the Centers for Disease Control (CDC), the Food and Drug Administration ... [more]

On April 28, USFDA issued the 4th edition of "Fish and Fishery Products Hazards and Controls Guidance” as required by the Food Safety Modernization Act (FSMA), which President Obama signed into ... [more]

Food industry readers will want to review the FDA's newly released "Strategic Priorities 2011-2015" document. 2011 and 2012 will be the critical years for the most sweeping changes in food regulation ... [more]

USFDA will fund a research study to evaluate market disruptions after major food recall-events in order to better understand the complex behavior of consumers, grocery retailers, and producers ... [more]

FDA has updated Chapter 7 (Recalls) of the Regulatory Procedures Manual. We attach a PDF of the revised Chapter 7 below as well as updated copies of Industry Guidance on Recalls and 21 CFR Part 7.
We ... [more]

We have posted below advance copies of proposed FDA rules on Restaurant and Vending Machine nutrition labeling rules as mandated by the Affordable Care Act of 2010. The final text will be published ... [more]

On March 30, USFDA released a "Background Document" reviewing health and labeling issues related to Certified Color Additives. The document reviews the "Southampton Study" commissioned by the United ... [more]

The Governmental Accountability Office (GAO), the investigative arm of Congress, has issued a report on "Federal Food Safety Oversight" which is critical of the continuing fragmentation of agency ... [more]

The USDA's Food Safety Inspection Service ("FSIS") has issued new standards for control of Salmonella and Campylobacter in poultry. Attached below is the March 16 Press Release as well as an Advance ... [more]

With the publication of two Federal Register Notices today, the FDA has taken the first administrative steps in the implementation process for the Food Safety Modernization Act ("FSMA").
Today's ... [more]

Senators Begich, Murkowski, Murray, and Wyden have introduced two bills in the opening days of the 112th Congress.
S-230 would prohibit USFDA from approving the marketing of genetically-engineered ... [more]

On January 31, USDA released the 2010 update of "Dietary Guidelines for Americans", 7th Edition. This document, issued every 5-years, and from an inherently cautious governmental agency, remains an ... [more]

FDA has issued the first Annual Report on the initial 12-months of operation of the Reportable Food Registry (September 2009 to September 2010). Participants in the farm-to-market value chain filed ... [more]

The GMA (Grocery Manufacturers Association) has made public a second FOP (Front of Package) labeling scheme which is called "Nutrition Keys". In 2010 the previous "Smart Choices" GMA initiative was ... [more]

The Government Accountability Office (the "investigative arm" of the US Congress) has issued another of its series of reports on Food Labeling issues. The report is titled "Food Labeling: FDA Needs ... [more]

THIS IS THE FIRST OF A SERIES OF ESSAYS ON THE FSMA WRITTEN BY CHARLES WOODHOUSE
THESE ESSAYS ARE DRAWN FROM THE MONTHLY FOOD SAFETY COLUMN WRITTEN BY CHARLES WOODHOUSE IN THE AMERICAN AGRICULTURAL ... [more]

The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced on December 29 that, effective January 1, 2012, it will require nutritional information panels for 40 of the ... [more]

The Food Safety Modernization Act has now passed both the House and Senate in the final days of the 111th Congress and heads for the desk of President Obama.
Posted below is the latest available GPO ... [more]

In three new documents released (pre-publication) to support testimony before Congress, the CDC estimates that each year 1 out of 6 Americans (or 48 million people) experiences a foodborne illness, ... [more]

On December 15, as part of its ongoing enforcement offensive to police the dietary supplements industry, the FDA issued a broad new warning about some dietary supplements, body-building products, and ... [more]

On December 13, President Obama signed the Healthy, Hunger Free Kids Act of 2010. The Act includes significant Food Safety program requirements for School Lunch Programs, recall provisions, and ... [more]

The Enrolled Senate version of the Food Safety Modernization Act (S-510 ES) is back in play.
Please see our post of December 7 for a discussion of the constitutional error made in the Senate on ... [more]

On November 30, with a vote of 73 to 25, the US Senate passed an amended version of S-510, the Food Safety Modernization Act. The action now moves to the House of Representatives in the final days of ... [more]

The European Food Safety Authority (EFSA) has published its 2010 Eurobarometer Survey Report on consumer perceptions of food related risks. Contamination of food with industrial chemicals is ... [more]

A team of researchers at Duke University has published an article criticizing the FDA methodology for the approval of GE (Genetically Engineered) Atlantic Salmon.
The article was published in the ... [more]

Students of Food Labeling will wish to note that the debate on labeling of GE (Genetically Engineered) Foods has now reached Australia and New Zealand. Australian Senator Nick Xenophon has introduced ... [more]

The Yale University Rudd Center on Food Policy & Obesity has issued a major report entitled Evaluating Fast Food Nutrition and Marketing to Youth. Our readers with interests in Food Labeling and ... [more]

On October 22, USFDA released a new 10-year Survey tracking food retail, restaurant, and food service industry efforts to control and reduce key food safety risk factors. In addition, USFDA has ... [more]

Funded by a grant from the National Institutes of Health (National Institute of Environmental Health Sciences), researchers at Johns Hopkins University have completed the largest study ever conducted ... [more]

The UK Food Standards Agency has issued warnings to importers on produce coated with wax containing morpholine as a carrier for glazing agents. The warning is primarily directed at apples since ... [more]

On October 13, the Canada Gazette published an Official Notice listing bisphenol A as a Schedule-1 Toxic Substance under the Canadian Environmental Protection Act, 1999. This Notice will pave the way ... [more]

Congresswoman Rosa DeLauro (D-CT), Chair of the Appropriations Agriculture Subcommittee (controlling the budget of USFDA and USDA) has issued what some may view as a direct challenge to USFDA ... [more]

The Institute of Medicine of the National Academies of Sciences has issued the first of two reports on Front-of-Package (FOP) Food Labeling
Examination of Front-of-Package Nutrition Rating Systems ... [more]

With an increasingly activist Federal Trade Commission (FTC) taking a more aggressive posture with regard to food label claims of an environmental nature, readers should note the first update of the ... [more]

Lawyers who are also trained and credentialed in the biological sciences will play a vital role in the development of the new field of Regulatory Food Science. In an important report, issued today, ... [more]

An important study on GHG Emissions and Food Waste has been published in Environmental Science and Technology. The authors include the noted agricultural efficiency researcher, Michael D. Webber of ... [more]

In an action which casts serious doubt upon the prompt approval of the first Genetically Engineered (GE) Animal by USFDA, eleven US Senators have written to FDA Commissioner Hamburg urging that the ... [more]

Using recombinant-based in vivo expression technology (RIVET), University of Florida researchers have discovered that tomato variety and maturity may influence the growth and prevalence of Salmonella ... [more]

On September 14, the Wall Street Journal published an important review article detailing the National Institutes of Health (NIH) research program that may lead to greater restrictions on structure / ... [more]

As Food Safety legislation moves forward in Congress, Senator Kirsten Gillibrand (D-NY) has emerged as one of the foremost Food Safety advocates in Congress. In March she introduced S-3114, a bill ... [more]

On August 26, FDA released a Background Document discussing its current thinking on the labeling of foods derrived from Genetically Engineered Salmon. This document is of significant interest in that ... [more]

Please see our July 12 posting for discussion of the new Shell-Egg Rule (74 FR 33030) which entered into effect on July 9, 2010 for producers with 50,000 or more layers at one farm. Below we have ... [more]

In coordination with the EFSA Advisory Forum, the Belgian Federal Public Service for Health, Food Chain Safety and the Environment is hosting a series of round tables on the role of science in the ... [more]

On August 9, the US Senate passed the "Healthy, Hunger-Free Kids Act" (Child Nutrition Act S-3307). This legislation now will move to the House in September (after recess) where passage is also ... [more]

USFDA has issued its Review Report on the first six-months of operations of the Reportable Food Registry (RFR). We have also included below the most recent Compliance Guide for the RFR updated to ... [more]

July 21, 2010 - USFDA today issued a Federal Register notice that explains how restaurants and similar retail food establishments not covered by the new federal menu labeling requirements, such as ... [more]

The European Food Safety Authority (EFSA) has issued a Scientific Opinion of its Scientific Committee - "Guidance on human health risk-benefit assessment of foods"
The document develops the EFSA ... [more]

On July 7, the Proposed Rule on Restaurant and Food Service Nutrition Information was published in the Federal Register. The Notice is attached below. We also attach Section 2572 of the Health Care ... [more]

Scientists at the University of London’s School of Hygiene and Tropical Medicine have published a review of the nutrition-related benefits to health of consuming organic foods in the American ... [more]

The USDA Economic Research Service has released a report on Local and Mainstream Food Supply Chains. Local, so called "Low Food Miles", food products have been rapidly gaining popularity with ... [more]

European Union Council Regulation (EC) No 834-2007 covering the production and labelling of organic products is now in full effect. We attach the complete text below. Readers should also understand ... [more]

In connection with potential contamination concerns raised by the Gulf Oil Spill, USFDA has issued a Letter to Industry reviewing regulations and requirements applicable to molluscan shellfish and ... [more]

Stanford University researchers have published a study in PNAS, the Proceedings of the National Academy of Sciences, documenting cumulative GHG (Greenhouse Gas) mitigation provided by agricultural ... [more]

On June 21, the US Supreme Court issued its long-awaited decision in Monsanto Company v. Geertson Seed Farms, 561 U.S. ___ (2010). In this important decision, the Supreme Court has lifted the ... [more]

As the European Union prepares for adoptions of major revisions in Food Labeling Regulations we post both the current law (Directive 2000 13 EC) and the Proposed Revisions. When the final text is ... [more]

Health Canada has issued a survey of BPA residual levels in common canned foods. The attached report summarizes the methodology of the survey and reports results. Health Canada has previously ... [more]

While food safety is also regulated by the USDA, the FDA oversees approximately 80 percent of the U.S. food supply, including all produce and seafood. Food safety experts and the public have ... [more]

The June issue of the USDA magazine "Amber Waves" presents a valuable update on the current status of organic farming in the USA and discusses challenges and opportunities for the future.
We also ... [more]

On May 24, the Government Accountability Office released the text of its April 23 letter to USFDA highlightings GAO findings that show significant gaps in FDA Food Safety Research and Programs. The ... [more]

The Produce Safety Project has issued another excellent report in its series. The report issued this week focuses on lessons that can be learned from the European Union’s Food Safety Policy. ... [more]

On May 6, the Government Accountability Office (GAO) issued an important update of the September 2009 Import Food Safety Report (GAO-09-873) previously posted on this Weblog.
For our reader's ... [more]

USFDA has opened a comment period for FOP (Front of Pack) food labeling. We have attached below the Federal Register Notice (75 FR 22602). This document contains an excellent discussion of FOP ... [more]

The USDA Inspector General released today a highly critical report on National Residue Program monitoring for pesticide, heavy metal, and antibiotic residues in the national meat supply. The report ... [more]

On March 30, the US Department of Agriculture Economic Research Service released data updated through 2008 on organic agriculture. A remarkable 15% annual growth of acreage dedicated to organic ... [more]

The Department of Health and Human Services Inspector General has issued a report on USFDA's inspection program for domestic food plants. The report documents an underfunded and under-resourced ... [more]

The Affordable Healthcare for America Act signed by President Obama on March 23 contains the Restaurant Labeling provisions that we discussed in our posting of 11/3/2010. To assist our readers we ... [more]

The Office of Inspector General of the USDA has issued a report that is sharply critical of USDA enforcement of the National Organic Program (NOP). The OIG Report highlights lax enforcement by USDA ... [more]

In a report released on March 18, the Government Accountability Office (GAO) was sharply critical of FDA in its handling of Food Irradiation Petitions on a timely basis. The report faults FDA for ... [more]

We are posting again (a year later) a review of COOL Labeling requirements in response to continuing questions that arise in connection with COOL implementation.
Country of Origin Labeling is a ... [more]

A February 2010 Report released by the Government Accountability Office finds significant shortcomings in USFDA's oversight of the GRAS determination process. The Report highlights significant ... [more]

On March 3, FDA Commissioner Hamburg issued the attached Open Letter to Industry on Food Labeling issues. Also attached is the list of Warning Letters issued in connection with this Open Letter. You ... [more]

The European Food Safety Authority has set up an EFSA scientific cooperation (ESCO) working group to collect and analyze information on the safety of substances used in non-plastic materials which ... [more]

The 2008 Organic Production Survey (OPS) is a follow-on survey to the 2007 Census of Agriculture. It is the first organic production and practices survey conducted on the national level by the U.S. ... [more]

The European Food Safety Authority (EFSA) has issued its 2008 Statistical Report on Zoonoses and Foodborne Human Illness within the European Union. Release date 1/28/2010.
Please see attached file. [more]

For the past year, Customs Brokers have been preparing their customers - international seafood and produce shippers should be prepared for a new phase of regulatory enforcement that will soon take ... [more]

The New York City Health Department announces the Natiuonal Salt Reduction Initiative on Ja. 11, 2010.
The Press Release and additional background information is attached below.
This program is ... [more]

The science and technology committee of Britain's upper house of parliament said, in a report issued on January 8, that use of nanoparticles in food and food packaging is likely to grow dramatically ... [more]

A new review from France has concluded that there are nutritional benefits to organic produce, on the basis of data compiled for the French food agency AFSSA. The conclusion opposes that of a UK ... [more]

The lack of Food Industry compliance with the Bioterrorism Preparedness and Response Act of 2002 is again in the news (See our Weblog posting of March 31, 2009). Compliance with the Food Facility ... [more]

In the Fall 2009 Federal Unified Agenda, FDA announced its intent to issue enforceable regulations in line with the August 2009 commodity specific guidance documents on leafy greens, tomatoes, and ... [more]

General function claims under Article 13.1 of Regulation (EC) No. 1924/2006 refer to the role of a nutrient or substance in growth, development and body functions; psychological and behavioral ... [more]

On November13, the Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) released a report from the Institute of Food Technologists (IFT), which recommends clear ... [more]

The Federal Register Notice (FR-74-211-56843-110309) on the forthcoming FDA / FSIS meeting has been posted below. There is a good deal of useful background information in the notice so it is well ... [more]

In a letter to Congresswoman Rosa DeLauro, important new conceptual guidance on USFDA's approach to FOP Labeling has been provided by Commissioner Margaret Hamburg. The Release, the Backgrounder, and ... [more]

In a major policy speech on October 17, USFDA's Michael Taylor announced new food safety requirements for fresh shellfish. The attached PDF file includes the policy speech text, a Backgrounder, a ... [more]

An updated version of the Agricultural Research Service's (ARS) flagship nutrient database has been launched by ARS, the principal intramural scientific research agency of the U.S. Department of ... [more]

The Food Safety Enhancement Act of 2009 (HR 2749) went to House Senate Conference on August 3. The amendment process is underway and we note an amendment introduced by Senator David Vitter (R, LA) ... [more]

The Pesticide Residues Committee of the UK's Food Standards Agency has released its controversial 2008 Pesticide Residues Annual Report. As was the case with the July report on Organic Foods, this ... [more]

The EU's Rapid Alert System for Food and Feed ("RASFF") has released its 2008 Annual Report on Border Refusals during 2008. For comparison purposes we also attach the September 2008 USDA-ERS EIB ... [more]

On September 8, USFDA initiated the active phase of the REPORTABLE FOOD REGISTRY. Industry personnel at all levels of the food industry value-chain must be familiar with the 24-hour reporting mandate ... [more]

Institute of Food Technologists (IFT) members should read the August 2009 Traceability Review in Food Technology. This material cannot be linked or posted here since it is copyrighted material on an ... [more]

Five years later, after great financial hardship imposed upon shrimp importers, the US Court of International Trade rules in favor of the industy and against USCBP on antidumping bonds placed to ... [more]

The release of the Organic Foods Health Effects Report by the UK Government (Food Standards Agency) has caused considerable consternation in the Organic Foods industry. However, I believe that most ... [more]

This article reviews the innovative Michigan State University programs - the Graduate Certificate in International Food Law and Regulation and the Professional Master of Science Food Safety program. [more]

As Congress moves on from Food Safety to Healthcare, here is the latest version of the Food Safety Enhancement Act of 2009 as released by Henry Waxman, Chair of the House Energy and Commerce ... [more]

The March 2009 release of the Food Traceability Investigative Report by the Health & Human Services Inspector General surprised both members of Congress and food industry observers by revealing ... [more]

The Government Accountability Office report on seafood fraud highlights a serious and growing problem n which the consumer is defrauded by species substitution and short-weight hidden by excess ... [more]

A pair of excellent reviews of current agricultural biotechnology issues has been released by the Congressional Research Service - one on plant biotechnology issues and the other on agricultural ... [more]